Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the ICU - A Randomized Controlled Trial (TANDOORI)

University Hospital, Angers

Status: Not yet enrolling

Conditions: Critical Care Nursing; Nursing Workload; Central Venous Catheter Related Infections; Intensive Care (ICU); Catheter-associated Bloodstream Infections (CLABSI)

Treatments: Procedure: 4-day infusion set replacement; Procedure: 7-day Infusion set replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT07183592

2025-A01509-40 (Other Identifier)

49RC24_0290

Details and patient eligibility

About

In the intensive care unit, patients' care and secure drugs administration require a central venous catheter. These invasive devices can lead to complications, particularly infections. Most preventive recommendations focus on catheter insertion, line handling, and dressings. Few recommendations adress catheter dwell time, which is certainly the main source of infection. Part of the prevention strategy is the regular and systematic replacement of infusion sets , as they may become contaminated during use, mainly through the hands of healthcare professionals. Prolonged use increases the risk of infection. Infusion lines changes involve disconnecting the old sets, discarding infusion devices containing drug residues, and replacing them with new sterile devices.

Current international guidelines recommend replacing these sets every 4 days, and the Center for Disease Control and Prevention recommends not exceeding 7 days. Replacing these devices requires the time of qualified nurses, numerous sterile medical devices, and medications. In addition to the intended effect on infection prevention, the procedure has impacts on workload and costs.

The objective of the study is to demonstrate that changing infusion set every 7 days does not increase the rate of central venous catheters related infections compared with changing infusion set every 4 days.

Enrollment: 2,830 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Adult patient
• Any ICU patient with a central venous catheter (inserted by venipuncture) in place for less than 72 hours and with an expected dwell time of at least 7 days
• Patient affiliated with or covered by a social security system
• Patient who has given verbal consent or written consent from a third party or in the event that the patient is unable to give consent.

Exclusion Criteria

• Patient with a documented bloodstream infection at the time of inclusion

• Patient whose central venous catheter has been in place for more than 72 hours

• Patient with suspected catheter-related infection

• Patient whose study catheter was inserted using a guidewire exchange

• Patient previously enrolled in the study during the same ICU stay

• Patient whose condition, according to the clinician, does not allow safe placement of a central venous catheter, such as:

  • Allergy to catheter material
  • Confirmed deep vein thrombosis at the time of insertion
  • Inflammatory skin disorder at the insertion site

• Patient admitted for extensive burns

• Inadequate understanding of the French language

• Pregnant, breastfeeding, or postpartum woman

• Person deprived of liberty by judicial or administrative decision

• Person receiving involuntary psychiatric care

• Person under legal guardianship or other legal protection measure

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,830 participants in 2 patient groups

7-day infusion set replacement

Experimental group

Description:

Infusion sets connected to the central venous catheter will be replaced every 7 days.

Treatment:

Procedure: 7-day Infusion set replacement

4-day infusion set replacement

Active Comparator group

Description:

Infusion sets connected to the central venous catheter will be replaced every 4 days.

Treatment:

Procedure: 4-day infusion set replacement